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68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03857087
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Radiological Society of North America
Information provided by (Responsible Party):
Michael Ohliger, MD, University of California, San Francisco

Brief Summary:
This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.

Condition or disease Intervention/treatment
Ovarian Carcinoma Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET)

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.

II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.

SECONDARY OBJECTIVES:

I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.

EXPLORATORY OBJECTIVES:

I. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.

II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging, and MRI-derived tumor perfusion.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After about 60 minutes, patients undergo PET/magnetic resonance imaging (MRI) for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.

After completion of study, patients are followed up at 28 days.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Gallium

Group/Cohort Intervention/treatment
Diagnostic 68Ga PSMA PET/MRI
Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/MRI for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.
Drug: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA-11
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga-68 labeled PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • PSMA-HBED-CC GA-68

Procedure: Magnetic Resonance Imaging (MRI)
Given PET/MRI
Other Names:
  • Magnetic Resonance Imaging
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging (NMRI)

Procedure: Positron Emission Tomography (PET)
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans [ Time Frame: Study Visit Day 1 ]
    Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging computed tomography/magnetic resonance imaging (CT/MRI). In addition, the mean, range, and standard deviation of standardized uptake value maximum (SUVmax) (across all visualized lesions per patient) and SUVmax-average (ave) (across all patients in the study cohort) will be descriptively reported.

  2. Number of overall ovarian cancer lesions detected by standard staging scans [ Time Frame: Study Visit Day 1 ]
    Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI.

  3. Average maximum standard uptake value (SUVmax) [ Time Frame: Study Visit Day 1 ]
    The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.

  4. Number of lymph nodes detected by PET [ Time Frame: Study Visit Day 1 ]
    Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.

  5. Number of lymph nodes detected by MRI [ Time Frame: Study Visit Day 1 ]
    Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.


Secondary Outcome Measures :
  1. Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens [ Time Frame: Study Visit Day 1 ]
    For patients undergoing surgical resection, the 68Ga PSMA-PET uptake will be correlated with PSMA expression in the primary tumor as well as metastatic sites. PSMA expression measurement is available as a core service from the cancer center



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population will be women with adnexal masses or other lesions suspicious for ovarian cancer metastases, who are scheduled for either resection or chemotherapy
Criteria

Inclusion Criteria:

  1. Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound):

    1. adnexal mass
    2. abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)
  2. Female,
  3. Age >= 18 years
  4. Creatinine </= 1.5 mg/dL
  5. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857087


Contacts
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Contact: Khadija Siddiqua 877-827-3222 Khadija.siddiqua@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Khadija Siddiqua    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Michael Ohliger, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Radiological Society of North America
Investigators
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Principal Investigator: Michael Ohliger, MD, PhD University of California, San Francisco
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Responsible Party: Michael Ohliger, MD, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03857087    
Other Study ID Numbers: 174017
NCI-2018-02331 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents